Guiding introducer for left atrium

ABSTRACT

A guiding introducer for in the left atrium comprised of a first, second and third section wherein the first section is a generally elongated straight section wherein merged with the distal end of the first section is a second section which is curved in a compound curve, first curving upward in a first longitudinal curve and simultaneously curving to the right in a second longitudinal curve, wherein the second section merges with the third section wherein said third section is a third longitudinal curve wherein the plane of the third section is angled upward at an angle of approximately 25 to about 60 degrees from the plane of the first section and wherein substantially all of the third section is coplanar.

BACKGROUND OF INVENTION

1. Field of Invention

This invention relates to introducers. More particularly, this inventionrelates to guiding introducers of specific shapes for use within theleft atrium of the human heart.

2. Prior Art

Introducers and catheters have been in use for medical procedures formany years. For example, one use has been to convey an electricalstimulus to a selected location within the human body. Another use is tomonitor and make measurements for diagnostic tests within the humanbody. Thus, catheters may examine, diagnose and treat while positionedat a specific location within the body which are otherwise inaccessiblewithout more invasive procedures. In use, catheters may be inserted intoa major vein or artery which is near the body surface. These cathetersare then guided to the specific location for examination, diagnosis ortreatment by manipulating the catheter through the artery or vein of thehuman body.

Catheters have become increasingly useful in remote and difficult toreach locations within the body. However, the utilization of thesecatheters is frequently limited because of the need for the preciseplacement of the tip of the catheter at a specific location within thebody.

Control of the movement of catheters to achieve such precise placementis difficult because of the inherent structure of a catheter. The bodyof a conventional catheter is long and tubular. To provide sufficientcontrol of the movement of the catheter, it is necessary that itsstructure be somewhat rigid. However, the catheter must not be so rigidas to prevent the bending or curving necessary for movement through thevein, artery or other body part to arrive at the specified location.Further, the catheter must not be so rigid as to cause damage to theartery or vein while it is being moved within the body.

While it is important that the catheter not be so rigid as to causeinjury, it is also important that there be sufficient rigidity in thecatheter to accommodate torque control, i.e., the ability to transmit atwisting force along the length of the catheter. Sufficient torquecontrol enables controlled maneuverability of the catheter by theapplication of a twisting force at the proximal end of the catheter thatis transmitted along the catheter to its distal end. The need forgreater torque control often conflict with the need for reduced rigidityto prevent injury to the body vessel.

Catheters are used increasingly for medical procedures involving thehuman heart. In these procedures a catheter is typically advanced to theheart through veins or arteries and then is positioned at a specifiedlocation within the heart. Typically, the catheter is inserted in anartery or vein in the leg, neck, upper chest or arm of the patient andthreaded, often with the aid of a guidewire or introducer, throughvarious arteries or veins until the tip of the catheter reaches thedesired location in the heart.

The distal end of a catheter used in such a procedure is sometimespreformed into a desired curvature so that by torquing the catheterabout its longitudinal axis, the catheter can be manipulated to thedesired location within the heart or in the arteries or veins associatedwith the heart. For example, U.S. Pat. No. 4,882,777 discloses acatheter with a complex curvature at its distal end for use in aspecific procedure in the right ventricle of a human heart. U.S. Pat.No. 4,117,836 discloses a catheter for the selective coronaryangiography of the left coronary artery and U.S. Pat. Nos. 5,016,640 and4,883,058 disclose catheters for selective coronary angiography of theright coronary artery. See also U.S. Pat. No. 4,033,031. Finally, U.S.Pat. No. 4,898,591 discusses a catheter with inner and outer layerscontaining braided portions. The '591 patent also discloses a number ofdifferent curvatures for intravascular catheters.

Thus, there are a number of patents which disclose catheters withpredetermined shapes, designed for use in specific medical proceduresgenerally associated with the heart or the vascular system. Because ofprecise physiology of the heart and the vascular system, catheters orintroducers with carefully designed shapes for predetermined uses withinthe human heart and vascular system are important.

Accordingly, it is an object of this invention to prepare a guidingintroducer for selected medical procedures in the left atrium.

It is a further object of this invention to prepare a guiding introducerfor use in selected electrophysiology procedures within the left atriumof the heart.

Another object of this invention is to prepare a guiding introducer foruse in selected ablation procedures within the left atrium of the heart.

These and other objects are obtained by the design of the guidingintroducers disclosed in the instant invention.

SUMMARY OF INVENTION

The instant invention is a guiding introducer to be used in the leftatrium comprised of a first, second and third sections wherein the firstsection is a generally elongated straight section which is merged at itsdistal end with the second and third sections which form a complexcurve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-section of the right side of the heart showing theright atrium and ventricle and the placement of the guiding introducer.

FIG. 2 is a cross-section of the left side of the heart showing themitral valve and the placement of the guiding introducer.

FIG. 3 is a perspective view of one embodiment of the guidingintroducer.

FIG. 4 is a perspective view of a second embodiment of the guidingintroducer.

FIG. 5 is a perspective view of a third embodiment of the guidingintroducer.

FIG. 6 is a perspective view of a fourth embodiment of the guidingintroducer.

DETAILED DESCRIPTION OF THE DRAWING

A typical human heart includes a right ventricle, a right atrium, leftventricle and left atrium. The right atrium is in fluid communicationwith the superior vena cava and the inferior vena cava. Theatrioventricular septum separates the right atrium from the rightventricle. The tricuspid valve contained within the atrioventricularseptum communicates the right atrium with the right ventricle. On theinner wall of the right atrium where it is connected with the leftatrium is a recessed portion, the fossa ovalis. See FIGS. 1 and 2. Inthe heart of a fetus, the fossa ovalis is open, permitting the fetalblood to flow between the right and left atria. In most individuals,this opening closes after birth, but in as many as 25 percent ofindividuals an opening still remains in the fossa ovalis between theright and left atria. Between the fossa ovalis and the tricuspid valveis the opening or ostium for the coronary sinus. The coronary sinus isthe large epicardial vein which accommodates most of the venous bloodwhich drains from the myocardium into the right atrium.

In the normal heart, contraction and relaxation of the heart muscle(myocardium) takes place in an organized fashion as electro-chemicalsignals pass sequentially through the myocardium from the atrial to theventricular tissue along a well defined route which includes theHis-Purkinje system. Initial electric impulses are generated at thesinuatrial (SA) node and conducted to the atrioventricular (AV) node.The AV node lies near the ostium of the coronary sinus in theinteratrial septum in the right atrium. The His-Purkinje system beginsat the AV node and follows along the membranous interatrial septumtoward the tricuspid valve through the atrioventricular septum and intothe membranous interventricular septum. At about the middle of theinterventricular septum, the His-Purkinje system splits into right andleft branches which straddle the summit of the muscular part of theinterventricular septum.

Sometimes abnormal rhythms occur in the heart which are referred to asarrhythmia. For example, a common arrhythmia is Wolff-Parkinson-Whitesyndrome (W-P-W). The cause of W-P-W is the existence of an anomalousconduction pathway or pathways that connects the atria muscle tissuedirectly to the ventricular muscle tissue, thus by-passing the normalHis-Purkinje system. These pathways are usually located in the fibroustissue that connect the atrium and the ventricle. In recent years atechnique has been developed to destroy these anomalous conductionpathways by delivering energy into the tissue in which the pathwaysexist. To accomplish this procedure a special electrode catheter ispositioned as close as possible to the anomalous conduction pathway tomaintain constant tissue contact while energy is delivered to destroythe pathway. This same type of contact with the cardiac tissue is alsonecessary when mapping or other procedures are employed relating tothese pathways.

One end of these anomalous conduction pathways can be located either inthe right atrium or in the left atrium with the other end of the pathwaylocated in the ventricle. When the anomalous conduction pathway islocated between the left atrium and the left ventricle, there are twoapproaches to positioning the catheter near that pathway for theappropriate medical procedure. One is to introduce the catheter into thefemoral artery by a standard introducer sheath and advance it up theaorta, across the aortic valve into the left ventricle and then attemptto position its tip under the mitral valve annulus near the anomalousconduction pathway. This approach is frequently difficult for manyreasons, including the difficulty in navigating the structure of theleft ventricle, the fact that it requires arterial access and thepotential problems associated with ablation of ventricular tissue, suchas sudden cardiac death. The other approach is to introduce atransseptal sheath apparatus, a long single plane curve introducer, intothe right femoral vein and advance it through the inferior vena cavainto the right atrium. A puncture is then made through the fossa ovalisin the interatrial septum and the apparatus is advanced into the leftatrium where the trocar and dilator of the apparatus are removed,leaving the sheath in position in the left atrium. The mapping orablation catheter is then inserted through the sheath and into the leftatrium and positioned on top of the mitral valve annulus near theanomalous conduction pathway. Specific positions may be chosen for themapping or ablation on the left side of the heart, includingspecifically posterorseptal, posterior, posterorlateral, lateral andanterolateral positions around the mitral valve annulus.

Traditionally, there have been two techniques for locating and ablatinganomalous conduction pathways which are situated between the rightatrium and right ventricle. Either method can be initiated by advancinga catheter through an access site into a vein in the leg, neck or upperchest.

The first technique, which approaches the pathway from the pathway'sventricular insertion site, involves entering the right atrium fromeither the inferior or superior vena cava, passing through the tricuspidvalve, and advancing toward the apex of the right ventricle. Then thecatheter is directed to make a 180 degree turn to reverse its path backup toward the right atrium and locate the accessory pathway under thetricuspid valve apparatus. The accessory pathway is then ablated fromthe ventricular insertion site under the tricuspid valve.

The second technique, which approaches the pathway from the atrialinsertion site, is to enter the right atrium from the inferior orsuperior vena cava, and attempt to locate the atrial insertion site ofthe accessory pathway around the tricuspid valve annulus. The accessorypathway is then ablated from the pathway's atrial insertion site on theatrial aspect of the tricuspid valve.

AV nodal pathways can be located and ablated from the right atrium.

Mere introduction of the catheter into the left atrium is not sufficientto effectively and efficiently perform these medical procedures,especially for the mapping or ablation of anomalous conduction pathways.These medical procedures are usually performed using a special catheter.The medical practitioners monitor the introduction of the catheter andits progress through the vascular system by a fluoroscope. Suchfluoroscopes do not easily identify the specific features of the heartin general and the critically important structures of the right and leftatrium in specific, thus making placement of the catheter difficult.This placement is especially difficult as the beating heart is in motionand the catheter will be moving within the right atrium and the leftatrium as blood is being pumped through the heart throughout theprocedure. The structure and shape of the guiding introducers of theinstant invention addresses and solves these problems.

Referring now to FIGS. 3 through 6, the guiding introducer of thepresent invention for use in the left atrium is comprised of a first,second and third section. The first section is a conventional, generallyelongated hollow, straight catheter section of sufficient length forintroduction into the patient and for manipulation from the point ofinsertion to the specific desired location within the heart.

Merged with the distal end of the first section of the sheath is thesecond section which is curved in a compound curve, curving first upwardand in a first longitudinal curve and simultaneously curving to theright in a second longitudinal curve. The first longitudinal curve has aradius of from about 0.5 cm. to about 2.0 cm. and preferably from about0.5 cm. to about 1.5 cm. The arc of the first longitudinal curve ispreferably from about 40 to about 60degrees and most preferably fromabout 45 to about 55 degrees of arc. The second longitudinal curve ofthe second section contains a radius from about 0.5 cm. to about 4.0cm., preferably from about 0.5 cm. to about 3.0 cm., and most preferablyfrom about 0.5 to about 2.0 cm. The second longitudinal curve ispreferably less than about 2.0 cm. in length.

The third section of the introducer is merged with the distal end of thesecond section. The structure of the third section of the guidingintroducer will depend on its intended use. In one embodiment (FIGS.3-5) the guiding introducer is used to place a mapping or ablatingcatheter in a position anterior to anterolateral to lateral toposterorlateral accessory pathways associated with the mitral valveannulus. To accomplish this, the third section is a third longitudinalcurve wherein the plane of the third section is angled upward at anangle of approximately 40 to about 60 degrees, preferably 45 to about 55degrees and, most preferably, 50 degrees from the plane of the firstsection and where substantially all of said third section is coplanar(at least within 15 degrees of coplanar).

To place sensing or ablating catheters at a specific location adjacentor left fibrous trigone, the arc of the third longitudinally curvedsection of the third section has a radius of about 35 to about 55degrees, preferably from about 40 to about 50 degrees and, mostpreferably, about 45 degrees. See FIG. 3.

This guiding introducer can also be used for analysis and treatment ofanterolateral to lateral accessory pathways of the mitral valve annulus.For this use the third longitudinally curved section of the thirdsection is comprised of an arc with the radius of about 80 to about 100degrees, preferably from about 85 to about 95 degrees and, mostpreferably, about 90 degrees. See FIG. 4.

The guiding introducer may also be used for analysis and treatment oflateral to posterolateral accessory pathways of the mitral valveannulus. In this embodiment the third longitudinally curved section iscomprised of an arc with a radius of about 125 to about 145 degrees,preferably 130 to about 140 degrees and, most preferably about 135degrees. See FIG. 5.

The guiding introducer may also be used for analysis and treatment ofposterolateral to posteroseptal accessory pathways of the mitral valve.A somewhat different structure is present for this embodiment because ofthe structure of that portion of the left atrium of the heart. (See FIG.6) While the first and second sections of this second preferredembodiment are the same as those of the first preferred embodiment, theangle of the plane of the third section in relationship to the plane ofthe first section is different. In this embodiment, the plane of thethird section is angled upward at an angle from about 25 to about 45degrees, preferably from about 30 to about 40 degrees, and mostpreferably about 35 degrees from the plane of the first section. In thisembodiment the longitudinally curved section of the third section iscomprised of an arc with a radius of about 170 to about 190 degrees,preferably 175 to about 185 degrees and, most preferably about 180degrees.

The distal tip of the introducer may be, and preferably will be, taperedto form a good transition with the dilator as is the case with manyintroducers.

The guiding introducer may be made of any material suitable for use inhumans and which has a memory or permits distortion from and subsequentsubstantial return to the desired three dimensional or complexmulti-planar shape. For the purpose of illustration and not limitation,the internal diameter of the tip of the guiding introducer may vary fromabout 6 to about 10 "French" (1 French equals about 1/3 of amillimeter). Such introducer can accept dilators from about 6 to about10 French and appropriate guidewires. Obviously, if larger or smallerdilators or catheters are used in conjunction with the guidingintroducers of the instant invention, modifications in size or shape canbe made to the instant guiding introducers.

The guiding introducer preferably may contain one or a multitude ofradioopaque tip marker bands near the terminus of the guidingintroducer. While various modifications may be made in the shapes byincreasing or decreasing its size or adding additional tip markers, itis critical to the successful location of the guiding introducer withinthe atrium that the shape be maintained.

The guiding introducer also preferably contains one or a plurality ofvents near the distal tip of the introducer, preferably three or four ofsuch vents. The vents are preferably located no more than about 5.0 to6.0 cm. from the tip of the introducer and more preferably 0.5 cm. toabout 4.0 cm. from the tip. The size of these vents should be in therange of about 40 to 601/1000 of an inch in diameter. These vents aregenerally designed to prevent air embolisms from entering the introducercaused by the withdrawal of a catheter contained within the guidingintroducer in the event the distal end of the introducer is ocluded. Forexample, if the tip of the introducer is placed against the myocardiumand the catheter located within the introducer is withdrawn a vacuum maybe created within the catheter if no vents are provided. If such vacuumis formed, air may be forced back into the introducer by thereintroduction of a catheter into the lumen of the introducer. Such airembolism could cause significant problems on the patient, including thepossibility of a stroke, heart attack or other such problems common withair embolisms in the heart. The addition of vents near the distal tip ofthe guiding introducers prevents the formation of such vacuum bypermitting fluid, presumably blood, to be drawn into the lumen of theintroducer as a catheter is being removed from the introducer, thuspreventing the possibility of the formation of an air embolism withinthe introducer.

Variances in size or shape of the instant guiding introducers are alsointended to encompass pediatric uses for the guiding introducer of theinstant invention although the preferred uses are for adult humanhearts. It is well recognized that pediatric uses may require reductionsin size of the various sections of the introducer, in particular thefirst section, but without any significant modification to the shape orcurve of the guiding introducer.

In operation, a modified Seldinger technique is normally used for theinsertion of the catheter into either an artery or vein of the body.Using this procedure, a small skin incision is made at the appropriatelocation to facilitate the catheter or dilator passage. The subcutaneoustissue is then dissected, followed by a puncture of the vessel with anappropriate needle with stylet positioned at a relatively shallow angle.The needle is then partially withdrawn and reinserted at a slightlydifferent angle into the vessel, making sure that the needle remainswithin the vessel. A soft flexible tip of an appropriate sized guidewireis then inserted through and a short distance beyond the needle into thevessel. Firmly holding the guidewire in place, the needle is removed.The wire guide is then advanced through the vessel into the inferiorvena cava or into the right atrium and finally the superior vena cava.With the wire guide in place, a dilator is then placed over the wirewith the guiding introducer placed over the dilator. The dilator andguiding introducer generally form an assembly to be advanced togetheralong the guidewire into the superior vena cava. After insertion of theassembly, the guidewire is then withdrawn. A Brockenbrough or trocarneedle is then inserted through the lumen of the dilator to the rightatrium to be used to create an opening through the interatrial septum,preferably at the fossa ovalis. The entire assembly (dilator sheath andBrockenbrough needle) is withdrawn from the superior vena cava into theright atrium so the tip rests against the intraatrial septum at thelevel of the fossa ovalis. The Brockenbrough needle is then advancedwithin the dilator to reach the fossa ovalis. After the opening is madethrough the interatrial septum, the needle, dilator and guidingintroducer are advanced into the left atrium. After the guidingintroducer of the instant invention is advanced through the interatrialseptum into the left atrium, the Brockenbrough or trocar and dilator areremoved, leaving the guiding introducer in the left atrium. The catheterto be used for analysis and/or treatment of the anomalous conductionpathways is then advanced through the lumen of the guiding introducerand is placed at an appropriate location near the mitral valve annulus.The choice of the guiding introducer to be used will depend on thelocation of the anomalous conduction pathway, as has previously beendiscussed.

By choice of the desired predetermined shape of the guiding introducerin conjunction with fluoroscopic viewing, the distal portion of theguiding introducer can be manipulated to direct the distal end of acatheter placed within the lumen of the guiding introducer, to aspecific internal surface with the left atrium. In addition, byproviding sufficient rigidity and support as the introducer is held inplace by the anatomical structure of the heart as well as thevasculature, the distal end of the guiding introducer can be maintainedin that fixed location or surface position of the endocardial structureto permit the appropriate procedures to be performed. If sensingprocedures are involved, the guiding introducer is placed in the desiredlocation. At that point, the electrical activity of the heart peculiarto that location can be precisely determined by use of a sensingelectrophysiology catheter placed within the guiding introducer.Further, as the guiding introducer permits precise location ofcatheters, an ablation catheter may be placed at a precise location fordestruction by the use of energy, for example, radiofrequency, thermal,laser or direct current. This precise location of the ablation cathetertip is important as there will be no dilution of the energy delivereddue to unfocused energy being dissipated over the entire cardiac chamberand lost in the circulating blood by a constantly moving tip of theablating catheter. This permits a significantly reduced amount of energyto be applied while still achieving efficient ablation. Further, timeused to perform the procedure is significantly reduced over procedureswhere no guiding introducer is used.

It will be apparent from the foregoing that while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that this invention belimited except as by the appended claims.

We claim:
 1. A guiding introducer to be used in the left atrium of ahuman heart comprised of a first, second and third section wherein thefirst section is a generally elongated straight section, wherein mergedwith a distal end of said first section is the second section, whereinthe second section is curved in a compound curve, curving in a firstlongitudinal curve and simultaneously curving in a second longitudinalcurve wherein the second section merges with the third section, whereinsaid third section is a third longitudinal curve, wherein the thirdsection is angled at an angle of approximately 40 to about 60 degreesfrom the first section, and wherein substantially all of said thirdsection is coplanar.
 2. The guiding introducer of claim 1 wherein aplurality of vents is provided near a distal tip of the introducer.
 3. Aguiding introducer to be used in the left atrium comprised of a first,second and third sections, wherein the first section is a generallyelongated straight section, wherein merged with a distal end of saidfirst section is the second section, wherein the second section iscurved in a compound curve curving in a first longitudinal curve with aradius of from about 0.5 cm. to about 2.0 cm. for about 40 to 60 degreesof arc, and simultaneously curving in a second longitudinally curvecontaining a radius of from about 0.5 cm. to about 4.0 cm., wherein saidsecond section is less than about 2.0 cm. in length, wherein distal endof said second section merges with the third section, wherein said thirdsection is a third longitudinally curved section with a radius of fromabout 1.5 cm. to about 4.0 cm., wherein said third section is angled atan angle of approximately 40 to about 60 degrees from the first section,and wherein substantially all of said third section is coplanar.
 4. Theguiding introducer of claim 3 wherein the third section is an arc of thethird longitudinally curved section with a radius of about 35-55degrees.
 5. The guiding introducer of claim 3 wherein the third sectionis an arc of the third longitudinally curved section with a radius ofabout 40-45 degrees.
 6. The guiding introducer of claim 3 wherein thethird section is an arc of the third longitudinally curved section witha radius of about 80-100 degrees.
 7. The guiding introducer of claim 3wherein the third section is an arc of the third longitudinally curvedsection with a radius of about 85-95 degrees.
 8. The guiding introducerof claim 3 wherein the third section is an arc of the thirdlongitudinally curved section with a radius of about 125-145 degrees. 9.The guiding introducer of claim 3 wherein the third section is an arc ofthe third longitudinally curved section with a radius of about 130-140degrees.
 10. The guiding introducer of claim 3 wherein a plurality ofvents is provided near a distal tip of the introducer.
 11. A guidingintroducer to be used in the left atrium of the human heart comprised ofa first, second and third section, wherein the first section is agenerally elongated straight section, wherein merged with a distal endof said first section is the second section, wherein the second sectionis curved in a compound curve curving in a first longitudinal curve andthen simultaneously curving in a second longitudinal curve, wherein adistal end of the second section merges with the third section which isa third longitudinal curve, wherein said third section is angled in anangle of about 25 to about 45 degrees from the first section, andwherein substantially all of said third section is coplanar.
 12. Theguiding introducer of claim 11 wherein a plurality of vents is providednear a distal tip of the introducer.
 13. A guiding introducer to be usedin the left atrium of the human heart comprised of a first, second andthird sections wherein the first section is a generally elongatedstraight section, wherein merged with a distal end of said first sectionis the second section, wherein the second section is curved in acompound curve first curving in a first longitudinal curve with a radiusof from about 0.5 cm. to about 2.0 cm. for about 40 to 60 degrees of arcand then simultaneously curving in a second longitudinal curvecontaining a radius of about 0.5 to about 4.0 cm., wherein said secondsection is less than about 2.0 cm. in length, wherein a distal end ofthe second section merges with the third section, which is a thirdlongitudinally curved section with a radius of from about 1.5 cm. toabout 4.0 cm., wherein the third section is angled at an angle of about25 to about 45 degrees from the first section, and wherein substantiallyall of said third section is coplanar.
 14. The guiding introducer ofclaim 13 wherein the third section is an arc of the third longitudinallycurved section with a radius of about 170-190 degrees.
 15. The guidingintroducer of claim 13 wherein a plurality of vents is provided near adistal tip of the introducer.